Australia TGA ARTG recordUterus-supporting pessary
Australia TGA ARTG Registered Device · Sigma Company Limited · MedGyn Products International Inc and MedGyn Products Inc · Class IIa · Started June 10, 2021
Good Name: Sigma Company Limited - Uterus-supporting pessary
- Risk Class
- Class IIa
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- June 10, 2021
- Effective Date
- June 10, 2021
- Country
- United States of America
- Address
- 100 West Industrial Road, Addison, Illinois, 60101
This is a device that is intended to be inserted into the vagina. This device is intended to be used for mild prolapse as well as urinary incontinence also for mild first-degree prolapse and used for an accompanying cystocele. The device is also intended to be used for second- to third-degree prolapse or procidentia, a rectocele as well as being effective in the prevention of exercise incontinence in women.
Access comprehensive regulatory information for Uterus-supporting pessary in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Sigma Company Limited, manufactured by MedGyn Products International Inc and MedGyn Products Inc in United States of America. The device registration started on June 10, 2021.
This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.